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Development and validation of stability indicating HPLC-MLC determination of dopamine agonist drug pramipexole | Abstract
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Abstract

Development and validation of stability indicating HPLC-MLC determination of dopamine agonist drug pramipexole

Author(s): K. V. V. Srikanth, K. R. S. Prasad, J. V. Shanmukha Kumar and K. Suresh Babu

A simple rapid,accurate and stability indicating HPLC method is described for the quantification of Pramipexole in bulk drug. Chromatographic quantification of Pramipexole is achieved on Xterra RP 18 column using isocratic Mobile phase of Sodium dodecyl sulphate, ethyl acetate,2-propanol and 0.2% Triflouroacetic acid in water (33:66:1:900,w/w) at a flow rate of 1.0mL/min with injection volume10μL. Column temperature was maintained at 30°C .The proposed method was validated for system suitability, linearity, precision, specificity, stability, Limit of Detection and Limit of quantification. Degradation studies were conducted as per ICH guidelines. Limit of Detection and Limit of Quantification of Pramipexole were 2.96μg/mL and 6.85μg/mL respectively. The proposed method can be used for routine analysis and stability studies.